Motility manometer priming manifold system with icon-based user interface and wireless connectivity

ABSTRACT

A catheter includes a distal distension balloon and circumferentially arranged motility measurement balloons proximal of the distension balloon. A manifold includes balloon ports each configured to fluidly couple to a motility measurement balloon, pressure transducer ports, and a priming port. A port selector is coupled to the manifold and movable between different positions. Each port selector position causes the manifold to establish different fluidic couplings between the respective motility balloon, pressure transducer, and priming ports. A pressure sensing device includes pressure transducers each fluidly coupled to one of the pressure transducer ports. The pressure sensing device is configured to coordinate calibration of the pressure transducers at atmospheric pressure with the port selector in a first position and motility balloon pressure measurements with the port selector in a third position. Priming of the motility measurement balloons is implemented by moving the port selector to a second position.

RELATED PATENT DOCUMENTS

This application claims the benefit of Provisional Patent ApplicationSer. Nos. 61/588,163 and 61/588,168 both filed on Jan. 18, 2012, towhich priority is claimed pursuant to 35 U.S.C. §119(e) and which arehereby incorporated herein by reference.

SUMMARY

Various embodiments are directed to apparatuses and methods forselectively coupling and decoupling fluidic pathways between amultiplicity of components of a pressurizable fluidic system.Embodiments are directed to a multi-mode manifold arrangement forselectively coupling and decoupling fluid connections between amultiplicity of components of a pressurizable fluidic system.Embodiments are directed to a multi-mode manifold arrangement forselectively coupling and decoupling fluid connections between amultiplicity of components of a pressurizable fluidic system thatrequires charging for proper operation.

Other embodiments are directed to pressure sensing devices thatincorporate an apparatus for selectively coupling and decoupling fluidicpathways between a multiplicity of device components. Embodiments aredirected to pressure sensing devices that incorporate a multi-modemanifold arrangement for selectively coupling and decoupling fluidconnections between a multiplicity of device components. Embodiments aredirected to apparatuses and methods for effecting selective fluidiccoupling and decoupling between charging, pressure sensing, and motilitymeasurement lumen components of a pressure sensing device that requirescharging for proper operation.

Further embodiments are directed to apparatuses and methods forselectively coupling and decoupling fluid pathways between amultiplicity of components of a motility manometer that requires primingfor proper operation. Embodiments are directed to a motility manometerfor measuring pressure changes in a body cavity which incorporates amulti-mode manifold arrangement for selectively coupling and decouplingfluid connections between charging, pressure sensing, and motilitymeasurement lumen components of a hand-held motility manometer.

Some embodiments are directed to a pressure sensing catheter comprisinga motility measurement balloon arrangement. In some embodiments, themotility measurement balloon arrangement includes a multiplicity ofmotility measurement balloons. In other embodiments, a single motilitymeasurement balloon is employed. The catheter includes a pneumaticconnector configured to mechanically and pneumatically connect to acorresponding pneumatic connector provided on a housing of a pressuresensing device or FOB (frequency operated button). In embodiments thatemploy a multiplicity of motility measurement balloons, the catheter'spneumatic connector incorporates a corresponding number of femaleconnectors each having a fluid channel that fluidly couples with aballoon lumen of the catheter (or receives a terminus of a balloonlumen). The female connectors are configured to matingly couple withcorresponding pins (male) of the housing's pneumatic connector. Each pinincludes a fluid channel that is configured to fluidly couple to acorresponding female connector. In some embodiments, the catheter'spneumatic connector is keyed to ensure proper alignment between thefemale fluid connectors and corresponding fluid pins of the housing'spneumatic connector when secured thereto. In some embodiments, thecatheter's pneumatic connector includes one or more male pins with fluidchannels, while the pneumatic connector of the FOB housing includes thefemale fluid connectors.

Various embodiments are directed to a pressure sensing device or FOBcomprising a multi-mode manifold and a plurality of pressuretransducers. The manifold is fluidly coupled to a pneumatic housingconnector, a priming port, and the pressure transducers. The pneumatichousing connector is configured to mechanically and fluidly couple to asingle- or multiple-channel connector of a pressure sensing catheter.The manifold is configured to provide selective coupling and decouplingbetween the pneumatic housing connector, the priming port, and thepressure transducers. In some embodiments, the pressure sensing deviceis configured to calibrate the pressure transducers at atmosphericpressure and initiate pressure measurements with both the pressuretransducers and the one or more motility measurement balloons of thepressure sensing catheter at atmospheric pressure. The pressure sensingdevice can incorporate a single or multi-port pneumatic connector of atype described herein. According to various embodiments, the pressuresensing device is incorporated in a hand-held housing which includes aport selector coupled to the manifold, a display, and a battery or otherpower source. In some embodiments, the pressure sensing device furtherincludes a distension balloon pressure transducer which is fluidlycoupled to a distension balloon connector on the housing. The distensionballoon connector is configured to fluidly couple to a distensionballoon lumen and distension balloon of a pressure sensing catheter. Thedistension balloon can be implemented as a compliant or semi-compliantballoon, which allows for cavity compliance testing (e.g., rectalcompliance testing).

According to some embodiments, a system includes a catheter comprising adistal distension balloon and a plurality of circumferentially arrangedmotility measurement balloons proximal of the distension balloon. Amanifold includes a plurality of balloon ports each configured tofluidly couple to one of the motility measurement balloons, a pluralityof pressure transducer ports, and a priming port. A port selector iscoupled to the manifold and movable between different positions. Each ofthe different port selector positions causes the manifold to establishdifferent fluidic couplings between the respective motility balloon,pressure transducer, and priming ports. A pressure sensing devicecomprises a plurality of pressure transducers each fluidly coupled toone of the plurality of pressure transducer ports. The pressure sensingdevice is configured to coordinate calibration of the pressuretransducers at atmospheric pressure with the port selector in a firstposition and motility balloon pressure measurements with the portselector in a third. The pressure sensing device is further configuredto coordinate priming of the motility measurement balloons with the portselector is in a second position.

In accordance with other embodiments, a system includes an anorectalmanometry catheter having a distal distension balloon comprising acompliant or semi-compliant balloon, and a single or a plurality ofcircumferentially arranged motility measurement balloons proximal of thedistension balloon. A manifold comprises a single or a plurality ofballoon ports each configured to fluidly couple to one of the motilitymeasurement balloons, a single or a plurality of pressure transducerports, and a priming port. A pressure sensing device comprises a rectalpressure transducer fluidly coupled to the distension balloon, and asingle or a plurality of pressure transducers each fluidly coupled tothe single or plurality of pressure transducer ports. The pressuresensing device is configured to coordinate calibration of the single orplurality of pressure transducers at atmospheric pressure with themanifold in a first position, and coordinate rectal compliancemeasurements using the rectal pressure transducer and motility balloonpressure measurements using the single or plurality of pressuretransducers with the manifold in a third position. The pressure sensingdevice is further configured to coordinate priming of the motilitymeasurement balloons with the manifold in a second position.

According to further embodiments, a method involves selectivelyestablishing different fluidic couplings between a distal distensionballoon and a plurality of circumferentially arranged motilitymeasurement balloons of a manometry catheter, a plurality of pressuretransducers, and a priming port of a multi-mode manifold in accordancewith different orientations of the manifold fluidly coupled thereto. Themethod also involves calibrating the pressure transducers at atmosphericpressure and charging the motility measurement balloons so as to inflatethe motility measurement balloons. After charging the motilitymeasurement balloons, the method involves exposing the motilitymeasurement balloons to atmospheric pressure. The method furtherinvolves operating the motility measurement balloons to perform motilitymeasurements.

These and other features can be understood in view of the followingdetailed discussion and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of pressure sensing system which includes amulti-mode manifold and a pressure sensing device in accordance withvarious embodiments;

FIG. 2A illustrates an embodiment of a pressure sensing system inaccordance with various embodiments;

FIG. 2B illustrates the port selector shown in FIG. 2A in differentpositions that provide for different functionality in accordance withvarious embodiments;

FIG. 3 shows fluidic interconnections between the ports of a multi-modemanifold when the port selector is in a first position for equalizingpressure within the system to atmospheric pressure in accordance withvarious embodiments;

FIG. 4 shows fluidic interconnections between the ports of a multi-modemanifold when the port selector is in a second position for primingmotility measurement balloons of the system in accordance with variousembodiments;

FIG. 5 shows fluidic interconnections between the ports of a multi-modemanifold when the port selector is in between a second position and athird position in accordance with various embodiments;

FIG. 6 shows fluidic interconnections between the ports of a multi-modemanifold when the port selector is in a third position for operating thepressure sensing system in accordance with various embodiments;

FIG. 7 shows various valve positions required to perform the differentactions illustrated in the table of FIG. 7 in accordance with variousembodiments;

FIGS. 8A-8C illustrate a multi-port pneumatic connector system inaccordance with various embodiments;

FIGS. 9 and 10 are flow charts that show a number of processes involvinga pressure sensing system in accordance with various embodiments; and

FIGS. 11-20 are graphical diagrams showing an icon-based user interfacefor a hand-held motility manometer in accordance with variousembodiments of the disclosure.

DETAILED DESCRIPTION

According to various embodiments, a multi-mode manifold arrangement isincorporated in a motility pressure measuring device for selectivelycoupling and decoupling fluid connections between charging, pressuresensing, and motility measurement lumen components of the device.Embodiments are directed to measuring pressure changes in a cavity ofthe body using a pressure measuring device that incorporates amulti-mode manifold arrangement for selectively coupling and decouplingfluid connections between charging, pressure sensing, and motilitymeasurement lumen arrangements of the device. According to variousembodiments, pressure measuring devices, such as manometers, can beconfigured for performing different types of manometry, includingesophageal, anorectal, urinary, and uteral manometry, among others.Esophageal manometry is a test that measures functioning of the lowersection of the esophagus. Esophageal manometry evaluates the loweresophageal sphincter valve that prevents stomach acids from refluxinginto the esophagus. Esophageal manometry aids a clinician in determiningwhether a patient's esophagus can properly move food into the stomach.

Anorectal manometry is a test performed to evaluate patients withconstipation or fecal incontinence. More specifically, anorectalmanometry is a test that measures the pressures of the anal sphinctermuscles, the sensation in the rectum, and the neural reflexes that areneeded for normal bowel movements. According to various testingapproaches, a catheter in the form of a small, short, and somewhatnarrow blunt tube is gently inserted into the rectum. The cathetercontains a balloon-like device at a location where it will come intocontact with the anal sphincter. The catheter is connected to a devicethat measures pressure (and pressure changes) during the test.

During the test, the small balloon is slightly inflated in the rectum toassess the normal reflex pathways. The patient may be asked to squeeze,relax, and sometimes push at various times. Anal sphincter musclepressures are measured during each of these maneuvers. Anal manometrymeasures how strong the sphincter muscles are and whether they relax asthey should during voiding. Anal manometry provides useful helpfulinformation to the clinician in treating patients with pelvic floorweakness, pelvic floor spasm, fecal incontinence or severe constipation.Based on the results of this test, and of surface (transcutaneous) EMGof the pelvic floor muscle if performed, the clinician prescribes atherapy, typically in the form of an individualized exerciseprescription, but sometimes medications as well, and oftenneuromodulation.

Turning now to FIG. 1, there is shown a block diagram of a pressuresensing system which includes a multi-mode manifold 10 and a pressuresensing device 50 in accordance with various embodiments. The followingdiscussion describes the multi-mode manifold 10 in the context of apressure sensing device implemented as a motility manometer configuredfor sensing pressure changes in a body cavity (e.g., esophagus,anal-rectal region, colon, urinary, uterus). It is understood that themulti-mode manifold 10 and other components of the system shown in thefigures of the disclosure can be incorporated in other pressurizablefluidic systems, including apparatuses other than pressure sensingdevices or systems.

The multi-mode manifold 10 and pressure sensing device 50, along withother components such as a power source, are housed in a hand-held orportable chassis. For example, a hand-held motility manometer isconfigured to incorporate the multi-mode manifold 10 and pressuresensing device 50 shown in FIG. 1, although other system configurationsare contemplated. The multi-mode manifold 10 includes a number of ports,including a multiplicity of balloon ports 20, a multiplicity of pressuretransducer ports 25, and a priming port 15. Different fluidicinterconnections between the various ports are achieved by moving a portselector 30, which can be moved to different positions for selectivelycoupling and decoupling various fluidic pathways through the multi-modemanifold 10. In some embodiments, the port selector 30 is manually movedto desired positions to effectuate different fluidic couplings betweenthe balloon ports 20, the pressure transducer ports 25, and the primingport 15. In other embodiments, an electric motor can be controlled tomove the manifold 10 so as to make the desired fluidic interconnections.

Each of the pressure transducer ports 25 of the multi-mode manifold 10is configured to fluidly couple to one of a multiplicity of pressuretransducers 58 provided on the pressure sensing device 50. The pressuresensing device 50 includes a number of components, including acontroller 52 and a wireless communication device 55, among othercomponents. According to some embodiments, the wireless communicationdevice 55 of the pressure sensing device 50 is configured to wirelesslycommunicate with an external device or system, such as a tablet PC 60.The tablet PC is configured to execute software for interfacing with andcontrolling the pressure sensing system. The tablet PC 60 may beconfigured with a touch sensitive screen that allows for touch drivenclinician interaction with the pressure sensing system via an icon-baseduser interface 65. According to alternative embodiments, the pressuresensing device 50 can include a wired communication interface ratherthan a wireless communication device 55. A wireless communication device55 affords the opportunity to eliminate all wires and cables between thetablet PC 60 or other processing device and a manometer thatincorporates the multi-mode manifold 10 and pressure sensing device 50.The tablet PC 60 preferably includes an icon-based user interface 65.

Incorporating a wireless communication device 55 into a hand heldmanometer allows motility measurements to be transmitted wirelessly to aseparate system or device, such as tablet PC 60. A motility manometerthat incorporates a wireless communication device 55 eliminates the needfor cables used in traditional manometry systems. This eliminates theneed for bulky cables that can cause issues during use near and aroundpatients, and isolates the patient from any potential electrical hazard.Readings taken by the pressure transducers 58 can be transmittedwirelessly to a tablet PC 60 loaded with motility software. Variouscommunication protocols can be implemented by the wireless communicationdevice 55, such as MICS, ISM, RF Wireless protocols (WiFiMax, IEEE802.11a/b/g/n, etc.), Bluetooth (high or low power methods), and ZigBeeor similar specification, such as those based on the IEEE 802.15.4standard, or other public or proprietary wireless protocol.

Each of the balloon ports 20 of the multi-mode manifold 10 is configuredto fluidly coupled to one of a multiplicity of motility measurementlumens 45, represented by lumens A through N in FIG. 1. Each of themotility measurement lumens 45 is fluidly coupled to one of amultiplicity of pressurizable lumens 102 of a pressure measuringcatheter 100. According to various embodiments, the pressure measuringcatheter 100 includes a shaft 105 having a distal end that supports twoballoon arrangements. In the embodiment of the pressure measuringcatheter 100 shown in FIG. 1, a distension balloon 120 is mounted at adistal end of the shaft 105, and a motility measurement balloonarrangement 110 is mounted proximal of the distension balloon 120. Themotility measurement balloon arrangement 110 includes either a single ora multiplicity of balloons, such as four such balloons (e.g., 4-6balloons). Each of the motility measurement balloons 110 is fluidlycoupled to one of the shaft lumens 102 and one of the motilitymeasurement lumens 45.

The lumen arrangement of the shaft 105 also includes a distal balloonlumen 103, labeled lumen DB, which is fluidly coupled to the distalballoon 120. The distal balloon lumen 103 is fluidly coupled to apressure transducer 59 of the pressure sensing device 50. The fluidconnection between the distal balloon lumen 103 and the pressuretransducer 59 can be routed through the multi-mode manifold 10 or canbypass the manifold 10. For example, and according to some embodiments,the distal balloon lumen 103 is fluidly coupled to a stopcock luerconnector located towards a proximal end of the catheter 100, and anextension tube 153 is provided to fluidly couple the distal balloonlumen 103 to the pressure transducer 59 via a luer connector. In someembodiments, the distension balloon 120 is configured as a compliant orsemi-compliant balloon, and therefore retains is round or ellipticalshape when inflated. Use of a compliant or semi-compliant distensionballoon 120 provides for testing of rectal compliance in additional toanorectal manometry measurements.

The fluid connections between the motility measurement lumens 45 andcorresponding balloon ports 20 provide for establishing independentfluid channels between each of the motility measurement balloons 110 ofthe pressure measuring catheter 100 and the multi-mode manifold 10.Fluidly coupling each of the pressure transducer ports 25 of themulti-mode manifold 10 to a corresponding pressure transducer 58 of thepressure sensing device 50 provides independent fluid channels betweeneach of the motility measurement balloons 110 of the pressure measuringcatheter 100 and individual pressure transducers 58 of the pressuresensing device 50.

FIG. 2A illustrates an embodiment of a pressure sensing system inaccordance with various embodiments. In some embodiments, the pressuresensing system 90 shown in FIG. 2A is implemented as a hand-held,portable anorectal manometry system. In some implementations, thecatheter section 100 of the pressure sensing system 90 is manufacturedas a disposable product, while the pressure sensing device 50 is areusable product. The catheter 100 of the pressure sensing system 90illustrated in FIG. 2A includes a shaft 105 which supports a distaldistension balloon 120 and a motility measurement balloons 110circumferentially arranged about the shaft 105. A series of depthindicators 115 is provided on the shaft 105 between the distensionballoon 120 and the motility measurement balloons 110. The depthindicators 115 are separated from one another by a predetermineddistance, such as 1 cm. The depth indicators 115 allow the clinician toknow how deep into a body cavity the distal end of the catheter 100 hasbeen inserted.

The number of, and spacing between, the depth indicators 115 variesdepending on the type of catheter being used and the body cavity beingexamined. In the case of an anorectal manometry catheter embodiment, forexample, between about 4 and 10 (e.g., 6) depth indicators 115 spaced 1cm apart is generally appropriate. In addition, an orientation indicator(not shown), such as “P” for posterior, can be provided on the shaft 105to indicate the rotational orientation of the catheter. This isimportant in some embodiments where different regions of anatomy arebeing tested using discrete motility measurement balloons 110. Forexample, anorectal motility measurements can be obtained using fourmotility measurement balloons 110 mounted on the shaft at 0°, 90°, 180°,and 270° locations about the circumference of the shaft 105. The fourballoons 110 at these locations are identified as posterior (P),anterior (A), left (L), and right (R) balloons, with the posterior (P)balloon referring to the balloon that is oriented to face the patient'sspine. By properly aligning the orientation indicator (e.g., “P”) on thecatheter shaft 105 with respect to a specified body reference point(e.g., the spine), the pressure measurements made using the 4 balloonsaccurately correspond to posterior, anterior, left, and right regions ofthe anal canal.

According to other embodiments, motility measurements (e.g., anorectalmotility measurements) can be obtained using a catheter having a singlemeasurement balloon mounted circumferentially about the shaft 105. Inconfigurations that employ a single motility measurement balloon, asingle channel of pressure data is obtained, which may be sufficient inmany applications. In some embodiments, the single balloon may extendpartially around the circumference of the catheter's shaft 105, such asan arc of 90°, 180°, or 270° for example.

It is noted that the typical length of the human anal canal rangesbetween about 20-45 mm. In various embodiments, the length of themotility measurement balloons 110 is about 20 mm. The relationship ofthe length of the motility measurement balloons 110 relative to theaverage length of a patient's anal cavity allows for viable anorectalmanometry testing to be conducted using a single site without need forrepositioning for a large majority of patients. At most, only twotesting sites would be needed, thus requiring only a singlerepositioning event for a small percentage of patients having a longerthan average anal canal (such patients constitute only about 15-20% ofthe population). Conventional anorectal manometry catheters typicallyemploy relatively short motility measurement balloons, requiring amultiplicity of tests to be performed at a multiplicity of anal canaldepths, resulting in additional time and costs.

FIG. 2A further shows a charging syringe 150 fluidly coupled to thedistension balloon 120. The charging syringe 150 is used to pressurizethe distension balloon 120 during use. In some embodiments, thedistension balloon 120 requires a minimal charge (e.g., 10 cc) to ensureproper operation. This minimal charge only partially inflates thedistension balloon 120. In some embodiments, the distension balloon 120has a length of about 55 mm, a diameter of about 30 mm, and can hold amaximum safe pressure of about 180 cc. The pressure within thedistension balloon 120 can be measured using a distension balloon (DB)pressure transducer (transducer 59 shown in FIG. 1) of the pressuresensing device 50, which can be fluidly coupled to the distensionballoon lumen in the catheter shaft via an extension tube 153 connectedbetween a single luer connector 155 and a stopcock luer connector 152.The stopcock luer connector 152 allows selective fluidic coupling anddecoupling between the charging syringe 150, the distension balloon 120,and the distension balloon pressure transducer 59 via the extension tube153. As previously discussed, the distension balloon 120 according tosome embodiments is implemented as a compliant or semi-compliantballoon, allowing for rectal compliance testing. Conventional anorectalmanometry catheters typically employ a compliant distension balloon thatexpands into the rectal cavity during inflation, rendering thedistension balloon unusable for rectal compliance testing.

The pressure sensing device 50 includes a hand-held housing 51 withinwhich a number of the aforementioned components are housed, includingthe multi-mode manifold 10, pressure sensing device electronics (e.g.,controller 52, wireless communication device 55, pressure transducers 58and 59), power supply (e.g., battery), and fluidic ports 15, 20, 25, andlumens 45. The housing 51 also supports a display 53, a priming port 15(with detachable cover shown), a port selector lever 30, a multi-portconnector 101, and a luer connector 155. It is noted that the pressuresensing device 50 in the housing 51 shown in FIG. 2A is also referred toas an FOB (frequency operated button).

The charging or priming port 15 is configured to receive a syringe orother charging device that contains a charged fluid (e.g., air). Thepriming port 15 can also be used to expose the multi-mode manifold andvarious fluidic couplings within the pressure sensing device 50 toatmospheric pressure, assuming the syringe is not positioned within thepriming port 15. The priming port 15 can be fluidly coupled to themotility measurement balloons 110 via the multi-mode manifold forcharging with a pressurized fluid (e.g., 3 or 4 cc of air) or exposed toair at atmospheric pressure. The priming port 15, when open, can alsoprovide a conduit to atmosphere for the pressure transducers 58. Thedisplay 53 includes a number of different indicators and buttons.According to some embodiments, the display 53 includes a power button, asystem on/off indicator (e.g., green=on), a battery status indicator,and a wireless connection button/status indicator (e.g., Bluetoothicon). It is understood that other indicators and buttons can beprovided to provide other functionality and information.

FIG. 2A further shows a port selector 30 in the form of a lever mountedon the side of the housing 51. The port selector 30 is coupled to themulti-mode manifold 10 and controls the movement (e.g., rotation) of themulti-mode manifold 10, which effectuates predefined fluidic couplingsbetween the four motility measurement balloon ports 20, the fourpressure transducer ports 25, and the priming/charging port 15, as shownin FIG. 1. Selected fluidic connections between these ports are coupledand decoupled depending on the position of the multi-mode manifold 10 ascontrolled by the port selector 30. These fluid connections are alsoreferred to herein as valves, and as such there are four balloon portvalves 20′, four pressure transducer valves 25′, and a priming portvalve 15′ (see FIG. 1).

As is best seen in FIG. 2B, and according to various embodiments, theport selector 30 has three main positions (e.g., forward, up, and down)that provide for different functionality. Intermediate port selectorpositions between these three main positions can provide additionalfunctionality. It is noted that the port selector 30 shown in FIG. 2A isin the forward position.

In the down position 30-D (also referred to herein as the firstposition) shown in FIG. 2B, and with reference also to FIG. 1, all ofthe balloon port valves 20′, the pressure transducer valves 25′, and thepriming port valve 15′ are open to atmosphere.

With the port selector 30 in the down 30-D, the motility measurementballoons 110, the pressure transducers 58, and the priming port 15equalize to atmospheric pressure. When the port selector 30 is in thedown position 30-D, the pressure transducers 58 can be calibrated atatmospheric pressure with the priming port 15 open to atmosphere (i.e.,charging syringe and valve cap removed from the priming port 15).

With the port selector 30 in the up position 30-U (also referred toherein as the second position), the pressure transducer valves 25′ areclosed to atmosphere and are also closed to the balloon port valves 20′and the priming port valve 15′. The priming port valve 15′ is open,which can be to atmosphere or a charging syringe situated on/in thepriming port 15. The balloon port valves 20′ are open to the primingport valve 15′. When the port selector 30 is in the up position 30-U,the motility measurement balloons 110 can be charged using a syringeplace within the priming port 15.

When the port selector 30 is moved to a position between the up position30-U and the forward position 30-F (also referred to herein as the thirdposition), the pressure transducer valves 25′ are closed and isolated.Lastly, when the port selector 30 is in the forward position 30-F, thepressure transducer valves 25′ are open, the balloon port valves 20′ areopen, and the priming port valve 15′ is closed. In the forward position30-F, the pressure transducers 58 are fluidly coupled to the motilitymeasurement balloons 110, and the system is ready for operation.

FIGS. 3-6 illustrate how moving the port selector 30 to differentpositions allows the clinician to selectively couple and decouplevarious fluidic pathways between the pressure transducer ports 25,balloon ports 20, and priming port 15 via the multi-mode manifold 10.FIGS. 3-6 also show an electronics board 51 of the pressure sensingdevice 50 which supports various electric and electronic components,including the pressure transducers 58. Not shown on the electronicsboard 51 is a pressure transducer 59 dedicated to measuring pressurewithin the distension balloon 120, as shown in FIG. 1. These and othercomponents are coupled to a controller 52 also mounted on theelectronics board 51.

Manometers need to be primed prior to use. The priming processinitializes the complete motility measurement system prior to use. Themulti-mode manifold 10 shown in FIGS. 3-6 is capable of beingincorporated into a hand-held manometer, allowing the charging of themotility measurement lumens while disconnected from the manometerpressure transducers 58. According to various embodiments, themulti-mode manifold 10 allows decoupling of manometer pressuretransducers 58 from the system prior to charging the motilitymeasurement lumens 110.

FIG. 3 shows various features of the multi-mode manifold 10, includingthe priming port 15, the pressure transducer ports 25, and the balloonports 20. FIG. 3 also shows internal features of the multi-mode manifold10, including fluidic connections that can be made between the primingport 15, the pressure transducer ports 25, the balloon ports 20, and aconnecting chamber 23 between these ports. A central longitudinal bore12 provided in a manifold block 11 is fluidly connected to each of theports 15, 20, and 25. Selective coupling and decoupling of the variousports 15, 20, and 25 is achieve by use of a port selector 30 configuredto be received by the central longitudinal bore 12, as is shown in FIG.3.

FIG. 3 shows the fluidic interconnections between the ports 15, 20, and25 when the port selector 30 is in a first position, which correspondsto the down 30-D position of the port selector 30 shown in FIG. 2B. Itis understood that the port selector 30 may have a configurationdifferent from that shown in FIG. 3 and other figures for makingdifferent fluidic interconnections between the ports 15, 20, and 25depending on desired functionality. With the port selector 30 in thedown position 30-D, all ports 15, 20, and 25 are open to atmosphere viathe priming port 15. This orientation of the multi-mode manifold 10allows the system to equalize at atmospheric pressure, and furtherallows initial atmospheric readings to be taken by the pressuretransducers 58 independent of the motility measurement lumens 45. Thepressure transducers 58 are zeroed out at atmospheric pressure by thecontroller 52 as part of the calibration procedure.

FIG. 4 shows the port selector 30 in the up 30-U position shown in FIG.2B. In the up 30-U position, the balloon ports 20 are connected to thepriming port 15 (and may also be connected to each other). The up 30-Uposition causes the multi-mode manifold 10 to fluidly couple only themotility measurement lumens 45 and the priming port 15, and keeps thepressure transducers 58 isolated. During the priming procedure, acharging syringe is fluidly connected to the priming port 15, typicallywith 3 or 4 cc of air, to charge the motility measurement balloons 110.

According to some embodiments, prior to completion of the primingprocedure, a pressure transducer calibration procedure is performed atatmospheric pressure, rather than at a charged pressure. It has beenfound by the inventor that calibrating the pressure transducers 58 atatmospheric pressure and then initiating pressure measurements with boththe pressure transducers 58 and the motility measurement balloons 110 atatmospheric pressure provides for a substantial increase in pressuremeasurement accuracy. It was found that after charging the motilitymeasurement balloons 110 and then returning the balloons 110 toatmospheric pressure, the balloon 110 substantially retained theirinflated volume. During the calibration procedure, the charging syringeis removed from the priming port 15 opening the motility measurementballoons 110 to atmosphere, and then the port selector 30 is moved tothe forward 30-F position, thereby connecting the calibrated transducerports 25 to the calibrated motility measurement balloons 110. Both thepressure transducers 58 and motility measurement balloons 110 are atatmospheric pressure which completes the calibration procedure.

FIG. 5 shows the port selector 30 in between the up 30-U position andthe forward 30-F position. In this intermediate position, the primingport 15 is disengaged (port valve 15′ is closed) before the pressuretransducers 58 are reconnected to the system. A port selector positionbetween the up 30-U position and the forward 30-F position isolates thecharging apparatus 40 from the motility measurement lumens 45. When theport selector 30 is advanced to the forward 30-F position, themulti-mode manifold 10 fluidly connects the pressure transducers 58 tothe motility measurement lumens 45. FIG. 6 shows the port selector 30 atthe forward 30-F position, allowing the system to be operated forconducting motility pressure measurements and rectal compliance testing.In this position, only the motility measurement lumens 45 (and thereforemotility measurement balloons 110 of the pressure measuring catheter100) are connected to individual pressure transducers 58. As waspreviously discussed, some embodiments employ a single motilitymeasurement balloon 110, in which a single pressure transducer 58 wouldbe fluidly coupled to the single motility measurement balloon 110 whenthe port selector 30 is moved to the forward 30-F position.

FIG. 7 shows various valve positions required to perform the differentactions illustrated in the table of FIG. 7. Each of the actionscorrespond to different steps of a procedure for priming a motilitymanometer using a multi-mode manifold 10 in accordance with someembodiments of the disclosure. In FIG. 7, the charging/priming device 40is a syringe. The multi-mode manifold 10 incorporates three distinctpathways to allow priming of the system. The design allows differentcombinations of fluid connections between the pressure transducers 58,charging/priming apparatus 40, and motility measurement lumens 45. Itwill be appreciated that a multi-mode manifold 10 allows thecharging/priming device 40 to be connected to the motility measurementlumens 45 independent of the pressure transducers 58. This allows thepriming to stay intact when isolating the charging apparatus 40 andconnecting the motility measurement lumens 45 to the pressuretransducers 58. Embodiments of a motility manometer that incorporate amulti-mode manifold 10 provide a charging method without the use of acharging chamber or structure.

FIGS. 8A-8C illustrate a multi-port pneumatic connector system inaccordance with embodiments of the disclosure. According to variousembodiments, a multi-port manometer pneumatic connector system isincorporated in a motility manometer to allow connection of multiplechannels of pressure sensing via one easy-to-connect connector. Motilitymanometers need to be connected to a pressure measuring source prior touse. Conventional systems contain multiple connectors which aredifficult to connect and can be incorrectly connected to a wrong channelby the user. Embodiments of a multi-port pneumatic connector systemprovide an easy-to-connect and keyed system to ensure proper orientationof the pressure measuring source.

The embodiment shown in FIGS. 8A-8C incorporates an off-the-shelfconnector housing (e.g., a standard connector manufactured by FischerConnectors, Inc.) which is modified (customized) to incorporate a moldedmulti-port insert for connecting the pressure measuring source to amating connector located on the housing of the manometer. The connectoris keyed to ensure proper orientation. The mating connector located onthe manometer housing contains multiple pins containing sealing ringsand an internal channel for transferring the pressure from the matingconnector. The pins are located in a custom housing which is assembledinto an off-the-shelf mating connector. The ring seals ensure nopressure leaks during use. Various embodiments incorporate two suchmating connectors (male and female) to join a motility pressuremeasurement catheter to a motility manometer. A multi-port manometerpneumatic connector system can be incorporated into various types ofmotility manometers, including esophageal, anorectal, urinary, anduteral manometers.

The multi-port pneumatic connector system illustrated in FIG. 8A is across sectional view of the connector system shown in FIG. 8B. Theconnector system includes a housing connector 101 and a mating catheterconnector 400. The housing connector 101 is mounted on a side of themanometer's housing 51 as shown in the embodiment of FIG. 2A. Thecatheter connector 400 is mounted at the proximal end of an extensioncatheter 107 which is fluidly coupled to the lumens 102 of the manometercatheter's shaft 105. The housing connector 101 is configured as a maleconnector, and the catheter connector 400 is configured as a femaleconnector.

The housing connector 101 includes a housing 501 within which four pins510 are situated. Each of the pins 510 includes a fluid channel 514 andmachined ring seals 512. The fluid channel 514 of each pin 510 isfluidly connected to a housing lumen 508 which terminates at a balloonlumen of the multi-port manifold of the pressure sensing device. In someembodiments, the pins 510 and the ring seals 512 are stainless steel.The catheter connector 400 includes a housing 401 within which each ofthe four catheter lumens 102 terminate. The core material 405 within thecatheter housing 401 is SANOPRENE according to some embodiments. Each ofthe catheter lumens 102 terminate with a lumen connector 403 which isconfigured to matingly engage a corresponding housing pin 510 andfluidly connect with the fluid channel 514 of the corresponding housingpin 510. A threaded nut 505 engages corresponding threads 503 on thehousing 501 to secure the pneumatic connection between the housingconnector 101 and the catheter connector 400.

FIG. 8C shows a key arrangement that guarantees proper orientationbetween the catheter and housing connectors 400 and 101. In theembodiment illustrated in FIG. 8C, the housing 501 of the housingconnector 101 includes a longitudinal key 525 which is configured to bereceived by a corresponding longitudinal slot (not shown) provided onthe housing 401 of the catheter connector 400. It is understood thatother keying features can be used other than the key and slotarrangement shown in FIG. 8C.

A multi-port manometer pneumatic connector system of the presentdisclosure can be incorporated in devices and systems other thanmanometers. It is to be understood that even though numerouscharacteristics of various embodiments have been set forth in theforegoing description, together with details of the structure andfunction of various embodiments, this detailed description isillustrative only, and changes may be made in detail, especially inmatters of structure and arrangements of parts illustrated by thevarious embodiments.

FIGS. 9 and 10 are flow charts that show a number of processes involvinga pressure sensing system of the disclosure in accordance with variousembodiments. Manometry testing in accordance with the embodiment shownin FIG. 9 involves charging 202 the motility measurement balloons of thecatheter, and calibrating 204 the pressure sensors that are used tomeasure pressure changes within the motility measurement balloons.Manometry testing according to FIG. 9 also involves performing 206motility measurements using the motility measurement balloons, andperforming 208 body cavity (e.g., the rectum) compliance testing usingthe distension balloon of the catheter.

Manometry testing in accordance with the embodiment shown in FIG. 10involves charging 222 the motility measurement balloons of the catheterto inflate these balloons, and subsequently equalizing 224 the motilitymeasurement balloons and pressure transducers to atmospheric pressure.Manometry testing according to FIG. 10 also involves calibrating 226 thepressure transducers at atmospheric pressure, performing 228 motilitymeasurements using the motility measurement balloons, and performing 230body cavity (e.g., the rectum) compliance testing using the distensionballoon of the catheter.

FIGS. 11-20 are graphical diagrams showing an icon-based user interfacefor a hand-held motility manometer in accordance with embodiments of thedisclosure. The icon-based user interface is preferably implemented on atablet PC and/or a medical grade PC. An icon-based user interfaceimplemented by software for use in taking motility measurementseliminates the need for highly skilled users that are required whenusing traditional manometry systems. Traditional motility systems usecomplex software for collecting motility data. An icon-based userinterface provides the clinician with intuitive visual instructions incontrast to traditional written instructions. Screen layout provides aneasy to use visual interface in contrast to traditional testing methods.

Turing now to FIG. 11, an overall work flow diagram shows threedifferent processes involving the use of an icon-based user interfacefor a hand-held motility manometer in accordance with variousembodiments. The overall work flow involves setup, testing, andreporting processes. The setup work flow involves pairing the pressuresensing device with the tablet PC, calibrating the pressure transducersin a manner previously discussed, inputting operator preferences by theclinician, and performing a manometer setup procedure. The clinician isguided through each of the processes by various screens presented to theuser on the icon-based user interface.

With reference to FIGS. 11 and 12, the manometer setup procedureinvolves priming the motility measurement balloons with a predeterminedvolume air (e.g., 3 cc) using a syringe 40 with the port selector lever30 in the up position. According to various embodiments, the setupprocedure also involves calibrating the pressure transducers atatmospheric pressure by moving the port selector lever 30 to the downposition and zeroing out the pressure transducers. The port selectorlever 30 may then be moved to the forward position, placing themanometer in the operating mode. The setup procedure further includesconnecting a charging syringe filled with a predetermined volume of air(e.g., 60 cc) to the catheter's stopcock luer connector. The manometeris now ready to be inserted into the destination body cavity of thepatient, which is a patient's anal canal in this illustrativeembodiment. The catheter is inserted into the anal cavity until adesired depth is reached. The operator charges the distention balloonwith 10 cc of air to allow pressure readings. The catheter is rotated sothat the orientation indicator (e.g., “P”) on the catheter shaft isfacing the patient's spine. After the clinician finishes enteringpatient data on a patient data screen 301 shown in FIG. 14, testing maythen commence.

FIGS. 15-20 show screen images of the icon-based user interface duringeach of six phases of testing. These six tests are well known and arereferred to as a resting test (FIG. 15), a squeeze test (FIG. 16), anexpel empty test (FIG. 17), and expel full test (FIG. 18), a sensationtest (FIG. 19), and an exhale test (FIG. 20). It is noted that the boxeslabeled P, L, A, and R in FIGS. 15-20 refer to the four distinctpositions of the four motility measurement balloons at posterior, left,anterior, and right positions. For each of the tests, a depth indicator302 shows the current depth of the catheter as indicated by the depthindicators on the catheter's shaft. A timer 304 shows the elapsed timefor each phase of the tests. Pressure measurements are recorded for eachof the tests.

In FIGS. 18 and 19, the icon-based interface for the expel full andsensation tests include a pressure reading icon for the distensionballoon. Referring particularly to FIG. 19, this interface allows theclinician to perform rectal compliance testing, which is availablebecause the distention balloon is implemented as a compliant orsemi-compliant balloon. Each of the four phases of the sensation test,sensation, desire, urgency, and pain, have discrete icons 310, 312, 314,and 316 which allows the clinician to enter or capture the distensionballoon pressure at which the patient provided feedback for these fourtests.

Referring once again to FIG. 11, the overall work flow involvesgenerating a variety of reports for different recipients. The variety ofreports includes reports showing data review screens, reports fordiagnostics, reports for insurance purposes, and various forms of dataexport (e.g., email, disc, etc.).

It is to be understood that even though numerous characteristics ofvarious embodiments have been set forth in the foregoing description,together with details of the structure and function of variousembodiments, this detailed description is illustrative only, and changesmay be made in detail, especially in matters of structure andarrangements of parts illustrated by the various embodiments.

What is claimed is:
 1. A system, comprising: a catheter comprising adistal distension balloon and a plurality of circumferentially arrangedmotility measurement balloons proximal of the distension balloon; amanifold comprising: a plurality of balloon ports each configured tofluidly couple to one of the motility measurement balloons; a pluralityof pressure transducer ports; and a priming port; a port selectorcoupled to the manifold and movable between different positions, each ofthe different port selector positions causing the manifold to establishdifferent fluidic couplings between the respective motility balloon,pressure transducer, and priming ports; and a pressure sensing devicecomprising a plurality of pressure transducers each fluidly coupled toone of the plurality of pressure transducer ports, the pressure sensingdevice configured to coordinate calibration of the pressure transducersat atmospheric pressure with the port selector in a first position andmotility balloon pressure measurements with the port selector in a thirdposition.
 2. The system of claim 1, wherein the pressure sensing deviceconfigured to: coordinate calibration of the pressure transducers atatmospheric pressure with the port selector in the first position;coordinate priming of the motility measurement balloons with the portselector in a second first position; and coordinate motility balloonpressure measurements with the port selector in the third position. 3.The system of claim 1, wherein: the manifold has an elongatedcylindrical shape and is mounted for rotation; and movement of the portselector causes the manifold to rotate and establish different fluidiccouplings between the respective motility balloon, pressure transducer,and priming ports at different rotational orientations.
 4. The system ofclaim 1, wherein the manifold comprises an elongated cylinder includingan arrangement of bores therethrough, the bores aligning and fluidlycoupling with different motility balloon, pressure transducer, andpriming ports at different rotational orientations corresponding to thedifferent port selector positions.
 5. The system of claim 1, wherein:the port selector at the first position causes the manifold to fluidlycouple the pressure transducer ports to atmospheric pressure; and theport selector at the third position causes the manifold to fluidlycouple the pressure transducer ports to the balloon ports and todecouple the priming port from the pressure transducer and balloonports.
 6. The system of claim 1, wherein the distension ballooncomprises a compliant balloon or a semi-compliant balloon.
 7. The systemof claim 1, further comprising a wireless communication deviceconfigured to wirelessly couple the system with an external device. 8.The system of claim 7, wherein the external device comprises a tablet PCconfigured to execute software for interfacing with and controlling thesystem.
 9. The system of claim 1, wherein: the manifold, the portselector, and the pressure sensing device are supported by a housingseparable from the catheter; and the catheter is a disposable catheter.10. The system of claim 1, wherein: the manifold, the port selector, andthe pressure sensing device are supported by a housing separable fromthe catheter; and a keyed multi-port connecter is supported by thehousing and fluidly coupled to the balloon ports of the manifold, thehousing connector configured to receive a keyed multi-port connector ofthe catheter, such that alignment between key features of the housingand catheter connectors ensure proper alignment with and fluidiccoupling between the balloon ports of the manifold and the motilitymeasurement balloons of the catheter.
 11. A system, comprising: ananorectal manometry catheter comprising: a distal distension ballooncomprising a compliant or semi-compliant balloon; and a single or aplurality of circumferentially arranged motility measurement balloonsproximal of the distension balloon; a manifold comprising: a single or aplurality of balloon ports each configured to fluidly couple to one ofthe motility measurement balloons; a single or a plurality of pressuretransducer ports; and a priming port; and a pressure sensing devicecomprising: a rectal pressure transducer fluidly coupled to thedistension balloon; and a single or a plurality of pressure transducerseach fluidly coupled to the single or plurality of pressure transducerports, the pressure sensing device configured to coordinate calibrationof the single or plurality of pressure transducers at atmosphericpressure with the manifold in a first position, and coordinate rectalcompliance measurements using the rectal pressure transducer andmotility balloon pressure measurements using the single or plurality ofpressure transducers with the manifold in a third position.
 12. Thesystem of claim 11, wherein the pressure sensing device is configured tocoordinate priming of the single or plurality of motility measurementballoons with the manifold in a second position.
 13. The system of claim11, wherein: the manifold has an elongated cylindrical shape and ismounted for rotation; and rotation of the manifold establishes differentfluidic couplings between the respective motility balloon, pressuretransducer, and priming ports at different rotational orientations. 14.The system of claim 11, wherein the distension balloon comprises acompliant balloon or a semi-compliant balloon.
 15. The system of claim11, further comprising a wireless communication device configured towirelessly couple the system with an external computing device.
 16. Thesystem of claim 11, wherein: the manifold and the pressure sensingdevice are supported by a housing separable from the catheter; and akeyed multi-port connecter is supported by the housing and fluidlycoupled to the balloon ports of the manifold, the housing connectorconfigured to receive a keyed multi-port connector of the catheter, suchthat alignment between key features of the housing and catheterconnectors ensure proper alignment with and fluidic coupling between thesingle or plural balloon ports of the manifold and the single or pluralmotility measurement balloons of the catheter.
 17. A method, comprising:selectively establishing different fluidic couplings between a distaldistension balloon and a plurality of circumferentially arrangedmotility measurement balloons of a manometry catheter, a plurality ofpressure transducers, and a priming port of a multi-mode manifold inaccordance with different orientations of the manifold fluidly coupledthereto; calibrating the pressure transducers at atmospheric pressure;charging the motility measurement balloons so as to inflate the motilitymeasurement balloons; after charging the motility measurement balloons,exposing the motility measurement balloons to atmospheric pressure; andoperating the motility measurement balloons to perform motilitymeasurements.
 18. The method of claim 17, wherein after exposing themotility measurement balloons to atmospheric pressure, the motilitymeasurement balloons substantially retain their inflated shape.
 19. Themethod of claim 17, wherein calibrating the pressure transducerscomprises zeroing out the pressure transducers at atmospheric pressure.20. The method of claim 17, wherein: calibrating the pressuretransducers comprises causing the manifold to fluidly couple thepressure transducers to atmospheric pressure; charging the motilitymeasurement balloons comprises causing the manifold to fluidly couplethe priming port with the motility measurement balloons and decouple thepressure transducers from the priming port and the motility measurementballoons, the priming port configured to receive a pressurized fluid forinflating the motility measurement balloons; and operating the motilitymeasurement balloons comprises causing the manifold to fluidly couplethe pressure transducers to the motility measurement balloons and todecouple the priming port from the pressure transducers and motilitymeasurement balloons.
 21. The method of claim 17, wherein the catheteris configured for anorectal manometry, the method further comprisingselectively inflating and deflating the distension balloon to performrectal compliance testing.
 22. The method of claim 17, furthercomprising wirelessly coordinating at least a portion of one or more ofthe establishing, calibrating, charging, and operating processes.